Geriatric Sarcopenia Draft Timeline for Obtaining Medicare Coverage and Reimbursement for Screening, Diagnosis and Treatment March 14, 2012 © Copyright 2010 Applied Policy, L.L.C., All Rights Reserved. Overview • Current Geriatric Sarcopenia Screening, Diagnosis and Treatment Options • Medicare Coverage and Reimbursement Objectives Expand Patient Access to Current Geriatric Sarcopenia Screening, Diagnosis and Treatment Options Pave the Way for New Therapeutics • Summary Timeline © Copyright RightsReserved Reserved. © 2010 2012,Applied AppliedPolicy, Policy L.L.C., LLC, AllAllRights 2 Current Geriatric Sarcopenia Screening, Diagnosis and Treatment Options © Copyright 2010 Applied Policy, L.L.C., All Rights Reserved. Geriatric Sarcopenia Screening • Elderly patients with observed declines in physical function, strength, or overall health potentially have geriatric sarcopenia • Geriatric sarcopenia should be specifically considered in patients who are: Bedridden Cannot independently rise from a chair Who have an unusually slow gait speed © Copyright RightsReserved Reserved. © 2010 2012,Applied AppliedPolicy, Policy L.L.C., LLC, AllAllRights 4 Geriatric Sarcopenia Diagnosis • A diagnosis of sarcopenia is consistent with: a low functional assessment score; and an objectively measured low muscle mass. • No specific ICD Code ICD-9 728.2 and ICD-10 M62.5, “muscle wasting, NEC” often does not support payable claims • Functional Assessment: Patients at risk for sarcopenia should undergo a functional assessment, such as the Short Physical Performance Battery (SPPB) or a gait speed test. • Objective Muscle Mass Measurement: Patients who meet the screening criteria should have a body composition assessment using dual energy x-ray absorptiometry (DXA) scan. © Copyright RightsReserved Reserved. © 2010 2012,Applied AppliedPolicy, Policy L.L.C., LLC, AllAllRights 5 Geriatric Sarcopenia Treatment Examples of current treatments for geriatric sarcopenia include: • Vitamins and other supplements • Nutrition therapy • Exercise / Training / Physical Therapy • Lifestyle Education / Counseling • Muscle stimulation by device • Drug interventions © Copyright RightsReserved Reserved. © 2010 2012,Applied AppliedPolicy, Policy L.L.C., LLC, AllAllRights 6 Geriatric Sarcopenia Medicare Coverage and Reimbursement Objectives © Copyright 2010 Applied Policy, L.L.C., All Rights Reserved. Access Expansion: Current Geriatric Sarcopenia Screening, Diagnosis & Treatment • Work to Expand Geriatric Sarcopenia Screening and Diagnosis Expand Access to Geriatric Sarcopenia Screening under Medicare Create a Geriatric Sarcopenia Diagnosis Code Establish generally accepted functional assessment • Support the Establishment of Clinical Guidelines for the Diagnosis and Treatment of Geriatric Sarcopenia • Eliminate Barriers to Non-Pharmaceutical Treatments © Copyright RightsReserved Reserved. © 2010 2012,Applied AppliedPolicy, Policy L.L.C., LLC, AllAllRights 8 Pave the Way for New Therapeutics • Create a Reimbursement Pathway for New Pharmaceutical Treatments For small molecule and self-administered biopharmaceuticals Establish USP categories and classes suitable for geriatric sarcopenia treatment Ensure any therapeutic and generic substitution rules are appropriate Non-self-administered drugs and biopharmaceuticals Ensure no restrictions on coverage at national and local levels Support award of unique billing codes Support CMS approval of HOPD pass-through status © Copyright RightsReserved Reserved. © 2010 2012,Applied AppliedPolicy, Policy L.L.C., LLC, AllAllRights 9 Summary Timeline: Medicare Coverage and Reimbursement Objectives © Copyright 2010 Applied Policy, L.L.C., All Rights Reserved. Geriatric Sarcopenia Medicare Reimbursement Timeline 2012 Draft Legislation 2013 2014 Introduction and Congressional Consideration Development/Approval of Clinical Guidelines 2015 Enactment 2016 2017 2018 CMS Implementation Development/Endorsement of Quality Metrics Modify CDC Health Risk Assessment Guidance Modify USP Categories and Classes Petition WHO for ICD-10 Update Work to Obtain Positive USPSTF Recommendation Drug Pipeline Analysis Medicare Input to Phase III Coverage/Reimbursement Issues Based on Testosterone © Copyright RightsReserved Reserved. © 2010 2012,Applied AppliedPolicy, Policy L.L.C., LLC, AllAllRights Support Patient Access and Coverage, Coding & Payment 11 Transforming Intention into Action (202) 558-5272 | jscott@appliedpolicy.com © Copyright 2010 Applied Policy, L.L.C., All Rights Reserved.